Invitation to comment

The TGA sought comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation.

Timetable

Interested parties should respond by close of business Tuesday, 7 November 2017.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

The purpose of this consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of business processes aimed at improving the regulation of complementary medicines in Australia. These reforms aim to ensure timely access to high quality, safe and effective complementary medicines for consumers and greater flexibility and efficiency in the evaluation process for industry, while ensuring an appropriate level of risk is applied to the evaluation of complementary medicines.

The scope of this consultation includes five elements:

Business processes to support the introduction of a three-tiered risk-based framework for the regulation of complementary medicines, with a new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (higher risk) pathways.

Use of reports from comparable overseas regulators for the assessment of new ingredients, new registered medicines and products assessed through the new listing pathway.

Broadening the range of acceptable sources of evidence for the assessment of ingredients proposed for use in listed medicines.

Introduction of legislated timeframes and a new fee structure for complementary medicine and ingredient assessments.

Submissions

Submissions may address any, or all, of the proposals in the consultation document or other identified issues. Submissions might include, for example, suggested improvements or an assessment of how the proposed change will impact on you.

Enquiries

Any questions relating to submissions should be directed to the Reform Coordination and Support Section by email to MMDR.Consultation@tga.gov.au or by telephone to our information line on 1800 020 653 (TGA information line, managed by the Regulatory Assistance Section).

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Privacy information

The TGA collects your personal information in this submission in order to:

contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.

help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).

seek feedback about how the consultation was undertaken.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

More information on consultations and privacy is included in the submission form and on our website.